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Catalyft PL Expandable Interbody System 6068076

by Medtronic Sofamor Danek, Inc.

Ref 6068076

Catalyft PL Expandable Interbody System 6068076 is a device classified as Class IIb in the EU and Class II in the US made by Medtronic Sofamor Danek, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI B-00763000246709), cleared under FDA 510(k) K210425 on 24 May 2021 and listed in FDA GUDID since 16 Jun 2021 (UDI-DI 00763000246709), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210425

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00763000246709 Basic UDI-DI 00763000246709UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000246709 UDI-DI Date16 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210425 Date24 May 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00763000246709 registered 22 Oct 2026 Active
  • FDA 510(k) K210425 decided 24 May 2021 Active
  • FDA GUDID UDI-DI 00763000246709 listed 16 Jun 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0580-2026 FDA Class II initiated 16 Sep 2025

    Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Timeline

4 dated events

  1. Cleared FDA 510(k) K210425
  2. Listed FDA GUDID 00763000246709
  3. Recall initiated FDA recalls Z-0580-2026
  4. Registered EUDAMED B-00763000246709

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Catalyft PL Expandable Interbody System
Generic name
Metallic spinal interbody fusion cage
Device name
Interbody Cage, Pl, Long
Model / reference
6068076
Primary DI / UDI-DI
00763000246709
Basic UDI-DI
B-00763000246709
510(k) Number
FDA product code
MAX
EMDN code
P09070101 Spinal cages
GMDN term
Metallic spinal interbody fusion cage
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Metallic spinal interbody fusion cage

Cleared under the same submission (K210425)

and 8 more cleared under K210425

Similar devices in this category

Other devices filed under SPINAL CAGES.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)